Regulatory Record: Wells Pharma of Houston LLC

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Wells Pharma of Houston LLC has 7 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per m… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Wells Pharma of Houston LLC, rated "high" severity in Argus HQ's classification: Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Wells Pharma of Houston LLC has 7 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

Does Argus HQ track new FDA actions for Wells Pharma of Houston LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Wells Pharma of Houston LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Wells Pharma of Houston LLC?

9 total: 0 warning letters, 7 recalls, 0 approval records, and 2 Form 483 inspection citations.

What is the most recent FDA action on file for Wells Pharma of Houston LLC?

May 6, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Wells Pharma of Houston LLC had product recalls?

Yes, 7 recalls on file. See the full history below for each one.

Related enforcement actions

• Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg… →
• Wells Pharma of Houston LLC — Class II recall: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma… →
• Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc… →
• Wells Pharma of Houston LLC — Class II recall: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL… →
• Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per m… →
• Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per… →
• Wells Pharma of Houston LLC — Class II recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20… →
• Wells Pharma of Houston LLC -- FDA 483: 4 observations (2026-04-13) →
• Wells Pharma of Houston LLC -- FDA 483: 6 observations (2025-03-28) →

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